MAUDE Adverse Event Report: ETHICON INC. ETHILON BLK 36IN USP2-0; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Catalog Number	F3232BH
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/20/2025.H6 component code: g07002 - device not returned.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested; the following was obtained: type of surgery: skin suture of an animal (species not specified).Problem: loosening an ethilon f3232b.During skin suture, after two tissue passages and without exerting excessive pressure, the needle became detached from the thread.The surgery could be completed, using a new thread, without affecting the animal.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A photo upon which this medwatch is based has been received, however, the photo evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that a patient underwent an animal procedure on (b)(6) 2025 and suture was used.During a suture the needle broke at the base, making the thread in question unusable.Attached is a photo of the break, and another of the product.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - no device problem found.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information: h6, d9, h3.H3 investigation summary: the product was returned to ethicon for evaluation.Five representative unopened samples were received for analysis.Product code f3232bh.Upon initial inspection of the sample, no external damages were observed on the external packets.In order to evaluate the condition of the returned samples, the packets were opened.The swage and attachment area were noted to be as expected.The tip and body of the needles were examined under magnification and no defects or needle breakage were found.In addition, the samples were tested by resistance test to needle and met the requirements.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: to avoid this kind of damage: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.The event described could not be confirmed as the device performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.H3 photo investigation summary: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photos show a single barrier folder labeled as f3232b that appears to be closed, and in a second image, a broken needle in the attachment area is visible in the image.Based on the photo review, the event reported is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the device was not returned our evaluation is limited.We value the opportunity to fully analyze the device upon its return.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: ETHILON BLK 36IN USP2-0
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22053742
• Report Number: 2210968-2025-05585
• Device Sequence Number: 15424809
• Product Code: GAR
• UDI-Device Identifier: 10705031239197
• UDI-Public: (01)10705031239197(17)291231(10)105P81
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: F3232BH
• Device Lot Number: 105P81
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown